How strong is the evidence for stem-cell therapy in Ulcerative Colitis?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is thin and mostly exploratory: the registry holds 15 records, 1 completed, 0 at Phase 3 or 4, and 5 stopped early (33%). MSC-specific work accounts for 11 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Ulcerative Colitis
The endpoint is endoscopic and histological remission alongside clinical scores, sustained to a year. Ulcerative colitis remits spontaneously and responds to dietary and stress changes, so symptom improvement without endoscopy proves nothing.
What we can say from registrations alone
- Volume: 15 registered studies since 2010.
- Maturity: 0 confirmatory-phase records.
- Delivery: 1 completed; 5 terminated, withdrawn or suspended.
- Scale: median planned enrolment 20 participants, largest 90.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT01075893 — Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer | n/a | Completed | 11 | Newcastle University | 2010-02 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Ulcerative Colitis research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Ulcerative Colitis?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is thin and mostly exploratory: 15 registered records, 0 at Phase 3/4 and 5 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Approval is product-and-indication specific and changes over time; check the FDA, EMA or your national regulator directly rather than relying on a clinic's summary.
Why do clinics cite hundreds of studies?
It converts activity into the appearance of proof. A hundred early-phase registrations do not add up to one adequately controlled result.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.